Mechanical apparatus and method for dilating and delivering a therapeutic agent to a site of treatment

Abstract

The present method comprises the steps of advancing the coated expansion member to the obstruction in a vessel and applying opposed forces on said expansion member in an axial direction to move the expansion member to an expanded configuration wherein the expansion member dilates the obstruction and the expansion member either passively or actively delivers a therapeutic agent or medicament to the obstruction.

1. A method for delivering a medicament to an obstruction in a body passageway comprising:
 providing a mechanical dilatation and drug delivery catheter, said catheter having an expansion member coated with a medicament, said expansion member being expandable between a first contracted configuration and a second expanded configuration; 
 applying electrical energy to said expansion member to electrically bond the medicament to said expansion member; 
 inserting the mechanical dilatation and drug delivery catheter within a body passageway; 
 advancing the mechanical dilatation and drug delivery catheter to a predetermined site within the body passageway; and 
 applying a force on said coated expansion member in an axial direction to move said expansion member between said first contracted configuration to said second expanded configuration wherein said expansion member dilates said obstruction or body passageway and delivers a medicament to an said obstruction or body passageway, 
 wherein the electrical energy is applied prior to insertion of the mechanical dilation and drug delivery catheter into the body passageway. 
 
   
   
     2. The method as recited in  claim 1  which further comprises the step of positioning a guidewire in the body passageway, and wherein said advancing step is accomplished by threading said expansion member over said guidewire. 
   
   
     3. The method as recited in  claim 1  which further comprises the step of allowing said expansion member to be in said second expanded configuration for a predetermined period of time after the dilatation step to further expose said obstruction to the medicament. 
   
   
     4. The method as recited in  claim 1 , wherein said medicament is an anticoagulant selected from the group consisting of D-Phe-Pro-Arg chloromethyl ketone, an RGD peptide-containing compound, heparin, an antithrombin compound, a platelet receptor antagonist, an anti-thrombin antibody, an anti-platelet receptor antibody, hirudin, hirulog, phe-pro-arg-chloromethyketone (Ppack), Factor VIIa, Factor Xa, aspirin, clopridogrel, ticlopidine, a prostaglandin inhibitor, a platelet inhibitor and a tick anti-platelet peptide, and combinations thereof. 
   
   
     5. The method as recited in  claim 1 , wherein said medicament is a promoter of vascular cell growth selected from the group consisting of a growth factor stimulator, a growth factor receptor agonist, a transcriptional activator, and a translational promoter, and combinations thereof. 
   
   
     6. The method as recited in  claim 1 , wherein said medicament is an inhibitor of vascular cell growth selected from the group consisting of a growth factor inhibitor, a growth factor receptor antagonist, a transcriptional repressor, a translational repressor, an antisense DNA, an antisense RNA, synthetic DNA compounds, especially those with backbones that have been modified to inhibit enzymatic degradation (e.g. phosphorothioate compounds and morpholino diamidate compounds), a replication inhibitor, an inhibitory antibody, an antibody directed against growth factors, a bifunctional molecule consisting of a growth factor and a cytotoxin, and a bifunctional molecule consisting of an antibody and a cytotoxin, double stranded DNA, single stranded DNA, single stranded RNA and a double stranded RNA and combinations thereof. 
   
   
     7. The method as recited in  claim 1 , wherein said medicament is selected from the group consisting of a cholesterol-lowering agent, a vasodilating agent, and agents which interfere with endogenous vasoactive mechanisms, estrogen, testosterone, steroid hormones, cortisol, dexamethasone, corticosteroids, thyroid hormones, thyroid hormones analogs, throid hormones antagonist, adrenocorticotrophic hormone, thyroid stimulating hormone, thyroid releasing factor, thyroid releasing factor analogs, thyroid releasing factor antagonists and combinations thereof. 
   
   
     8. The method as recited in  claim 1 , wherein said medicament is a smooth muscle inhibitor selected from the group consisting of an agent that modulates intracellular calcium binding proteins, a receptor blocker for contractile agonists, an inhibitor of the sodium/hydrogen antiporter, a protease inhibitor, a nitrovasodilator, a phosphodiesterase inhibitor, a phenothiazine, a growth factor receptor agonist, an anti-mitotic agent, an immunosuppressive agent, and a protein kinase inhibitor, and combinations thereof. 
   
   
     9. The method as recited in  claim 1 , wherein said medicament is a compound of Paclitaxel, Paclitaxel analogs, Rapamycin, Actinomycin D, Methotrexate, Doxorubicin, cyclophosphamide, and 5-fluorouracil, 6-mercapatopurine, 6-thioguanine, cytoxan, cytarabinoside, cis-platin, chlorambucil, busulfan, and any other drug that can inhibit cell proliferation, and combinations thereof. 
   
   
     10. The method as recited in  claim 1  further comprising a plurality of said medicaments coated on at least a portion of said expansion member. 
   
   
     11. The method as recited in  claim 1  further comprising utilizing iontophoresis to facilitate the transport of the medicament to enhance tissue penetration. 
   
   
     12. The method as recited in  claim 1  further comprising providing a flow of current to the coated expansion member. 
   
   
     13. The method as recited in  claim 1  further comprising supplying a container including medicament. 
   
   
     14. The method as recited in  claim 13  further comprising immersing the expansion member into the container to coat a plurality of flexible elongate members which comprise the expansion member. 
   
   
     15. The method as recited in  claim 14  wherein the expansion member is coated prior to insertion of the mechanical dilation and drug delivery catheter within the body passageway. 
   
   
     16. The method as recited in  claim 1  wherein the applied energy creates an electrical charge that is opposite to an electrical charge of the medicament.